RISPERIDONE 1 mg /Ml Roztwór Doustny

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1. RISPERIDONE MYLAN GENERICS 1 mg/ml oral solution
   1. What is Risperidone Mylan Generics and what it is used for
   2. What you need to know before taking Risperidone Mylan Generics
   3. How to take Risperidone Mylan Generics
2. risperidone doses must be halved. Dose increases must occur more slowly in
   1. Possible side effects
   2. How to store Risperidone Mylan Generics
   3. Contents of the pack and other information

RISPERIDONE MYLAN GENERICS 1 mg/ml oral solution

risperidone

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

• 1. What Risperidone Mylan Generics is and what it is used for
• 2. What you need to know before you take Risperidone Mylan Generics
• 3. How to take Risperidone Mylan Generics
• 4. Possible side effects
• 5. How to store Risperidone Mylan Generics
• 6. Contents of the pack and other information

1. What is Risperidone Mylan Generics and what it is used for

Risperidone Mylan Generics belongs to a group of medicines called “antipsychotics”.
Risperidone Mylan Generics is used for:

• Treatment of schizophrenia, a condition in which you may see, hear or feel things that are not there, believe things that are not true or feel suspicious in an unusual way or be confused.
• Treatment of mania, a condition in which you may feel very excited, euphoric, agitated, exhilarated or hyperactive. Mania occurs during an illness called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who harm themselves or others. Non-pharmacological alternatives must have been adopted before treatment.
• Short-term treatment (up to 6 weeks) of persistent aggression in children with intellectual disability (aged 5 years and over) and adolescents with conduct disorder.

Risperidone Mylan Generics can help relieve the symptoms of the illness and prevent its
recurrence.

2. What you need to know before taking Risperidone Mylan Generics

Do not take Risperidone Mylan Generics:

• If you are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Mylan Generics if:

• You are taking furosemide (a diuretic that is used to reduce swelling and fluid retention caused by various medical problems including heart or liver problems)
• You have a heart problem. Examples include an irregular heartbeat, if you have weakness of the heart muscle (heart failure), have had a heart attack, or if you tend to have low blood pressure or if you are taking medicines for blood pressure. Risperidone can cause a lowering of blood pressure. Your dose may need to be adjusted.
• You are aware of any factors that could expose you to the risk of stroke, such as high blood pressure, cardiovascular disorders or circulatory disorders of the brain.
• If you are aware of any factors that promote the formation of a blood clot, for example if you smoke, or have smoked, or if you are likely to be immobile for a prolonged period (for example after surgery or illness)
• If you or someone in your family has a history of blood clots, as drugs of this type have been associated with the formation of blood clots
• You have, or have had, a low number of white blood cells in your blood, especially if this happened when you took other medicines
• You have experienced involuntary movements of the tongue, mouth and face
• You have had a condition whose symptoms included fever, muscle rigidity, sweating or reduced level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You suffer from Parkinson's disease (a brain disease that affects movement, such as tremor, rigid posture, slow and shuffling movements) or dementia (a widespread decline in all areas of mental ability such as memory loss and other mental functions), especially Lewy body dementia (abnormal aggregates of proteins that develop within nerve cells in Parkinson's disease)
• You are diabetic or at risk of developing diabetes (may have an increased concentration of sugars in the blood).
• You suffer from epilepsy
• You are a man and have experienced a prolonged or painful erection.
• You have difficulty controlling your body temperature or excessive heating.
• If you are, or become, dehydrated during treatment or have a reduced blood volume (hypovolemia)
• You have low levels of potassium or magnesium in your blood
• You have kidney problems
• You have liver problems
• You have an abnormally high level of the hormone prolactin in your blood or have a tumor that may depend on prolactin.

If you are not sure whether any of the conditions mentioned above apply to you, talk to your
doctor or pharmacist before using Risperidone Mylan Generics.

During treatment
Risperidone Mylan Generics can cause changes in the number of white blood cells, which help to
fight infections, therefore, before and during treatment your doctor may request blood tests.
Risperidone Mylan Generics can cause an increase in your weight. Significant weight gain can have a
negative impact on your health. Your doctor should measure your body weight regularly.
Since patients who have taken Risperidone Mylan Generics have been observed to have
diabetes mellitus or worsening of pre-existing diabetes mellitus, the doctor should check for
the presence of signs related to an increase in blood sugars. In patients with pre-existing
diabetes mellitus, blood sugar levels should be monitored regularly.
Risperidone often increases the levels of a hormone called "prolactin". This can cause side
effects such as menstrual irregularities and fertility problems in women, breast enlargement in
men (see “Possible side effects”). If you experience such side effects, it is
recommended to evaluate the level of prolactin in the blood.

If you are planning to undergo eye surgery, be sure to inform your doctor or
hospital staff that you are taking this medicine. During cataract surgery
(an opacity of the eye's lens), this medicine may have effects on the pupil or iris
(colored part of the eye), and this may cause damage to the eye.

Elderly patients with dementia
In elderly patients with dementia there is an increased risk of stroke (also known as transient
ischemic attack or TIA). If your dementia is caused by stroke you should not take risperidone.
During treatment with risperidone you should see your doctor frequently.
If you or the person assisting you notice a sudden change in your mental state or
sudden weakness or numbness of face, arms or legs, especially on one
side, or incomprehensible speech, even for a short period of time, it is
necessary to seek immediate medical attention. These may be signs of a stroke.

Children and Adolescents
Before starting treatment for behavioral disorder, other causes for
aggressive behavior must be excluded.
Before starting treatment, your child's body weight must be measured and must
be checked regularly during treatment.
If fatigue occurs during treatment with risperidone, changing the time of
administration of the drug may improve attention difficulties.
A small and inconclusive study has recorded an increase in height in children who have
taken risperidone, but it is not known whether this is an effect of the drug or is due to some other
reason.

Other medicines and Risperidone Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is particularly important to inform your doctor or pharmacist if you are taking any of
the following:

• Medicines that act on your brain, to help you calm down (benzodiazepines), or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase the sedative effects of all these medicines.
• Medicines that could change the electrical activity of your heart, such as medicines for malaria (such as quinine and mefloquine), medicines for heart rhythm problems (such as quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), for allergies (antihistamines), some tetracyclic antidepressants (such as maprotiline) or other medicines for mental problems.
• Medicines that cause a slowing of the heartbeat, such as beta-blockers or verapamil (used in the treatment of high blood pressure or angina).
• Medicines that cause a lowering of potassium in the blood (e.g. some diuretics).
• Medicines to treat high blood pressure. Risperidone Mylan Generics can cause a lowering of blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate)
• Medicines for urination (diuretics), used for heart disorders or for swelling of parts of the body, due to an accumulation of fluids (such as furosemide or chlorothiazide). Risperidone Mylan Generics taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• Rifampicin (a medicine to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone:

• Quinidine (used for some heart diseases)
• Antidepressants such as paroxetine, fluoxetine, sertraline, fluvoxamine, tricyclic antidepressants (such as amitriptyline)
• Medicines known as beta blockers and verapamil (used for the treatment of high blood pressure)
• Phenothiazines, oral paliperidone (used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for the treatment of fungal infections)
• Some medicines used in the treatment of HIV/AIDS, such as ritonavir

If you start or stop taking these medicines, you may need a different dose of
risperidone.
If you are not sure whether any of the conditions mentioned above apply to you, talk to your
doctor or pharmacist before using Risperidone Mylan Generics.

Taking Risperidone Mylan Generics with alcohol
During treatment with Risperidone Mylan Generics you should avoid drinking alcohol.

Pregnancy, breastfeeding and fertility

• If you are pregnant, if you think you may be pregnant, if you are trying to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist before using this medicine. Your doctor will decide if you can use it.
• The following symptoms may occur in newborns of mothers who have taken Risperidone Mylan Generics during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and feeding problems. If your baby shows any of these symptoms, you should contact your doctor.
• Risperidone Mylan Generics can increase the levels of a hormone called "prolactin" which can affect fertility in both female and male patients (see section 4 “Possible side effects”).

Driving and using machines
During treatment with Risperidone Mylan Generics dizziness, fatigue
and vision problems may occur. Do not drive, or use tools or machines, until you have spoken to
your doctor.

Risperidone Mylan Generics contains benzoic acid (E210)
This medicine contains less than 1.5 mg of benzoic acid in each millilitre of oral solution.
Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns (up to
4 weeks of age).

3. How to take Risperidone Mylan Generics

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

The recommended dose is as follows:
For the treatment of schizophrenia
Adults

• The starting dose is generally 2 mg per day, which may be increased to 4 mg daily from the second day.
• Your dosage may then be increased by your doctor depending on how you respond to treatment.
• Most people feel better with daily doses between 4 mg and 6 mg.
• The total daily dose can be divided into one or two administrations. Your doctor will tell you what the best dose is for you.

Elderly

• Your starting dose will generally be 0.5 mg twice a day.
• Your dose may then be gradually increased by your doctor to 1-2 mg twice a day.
• Your doctor will tell you what the best dose is for you.

For the treatment of mania
Adults

• Your starting dose will generally be 2 mg once a day.
• Your dose may then be gradually adjusted by your doctor, depending on your response to treatment.
• Most people will feel better with doses between 1mg and 6 mg once a day.

Elderly

• Your starting dose will generally be 0.5 mg twice a day.
• Your dose may then be gradually adjusted by your doctor up to 1 - 2 mg twice a day, depending on your response to treatment.

For the treatment of persistent aggression in people with Alzheimer's dementia
Adults (including the elderly)

• Your starting dose will generally be 0.25 mg twice a day.
• Your dose may then be gradually adjusted by your doctor, depending on your response to treatment.
• Most people will feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day.
• The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone Mylan Generics for schizophrenia and mania.

For the treatment of conduct disorder in children and adolescents
The dose will depend on your child's weight:
For children weighing less than 50 kg:

• The starting dose will generally be 0.25 mg once a day.
• The dose may be increased every other day with increments of 0.25 mg per day.
• The maintenance dose is generally between 0.25 mg and 0.75 mg once a day.

For children weighing 50 kg or more:

• The starting dose will generally be 0.5 mg once a day.
• The dose may be increased every other day with increments of 0.5 mg per day.
• The maintenance dose is generally between 0.5 mg and 1.5 mg once a day.

The duration of treatment in patients with conduct disorder should not exceed 6
weeks.
Children under 5 years of age should not be treated with Risperidone Mylan Generics for
conduct disorder.

Patients with kidney or liver problems
Regardless of the disease to be treated, all initial doses and subsequent doses of

risperidone doses must be halved. Dose increases must occur more slowly in

these patients.
Risperidone must be used with caution in this patient group.

How to take Risperidone Mylan Generics
Your doctor has indicated the amount of medicine to take and for how long. This
depends on your condition and varies from person to person.
The solution is supplied with a syringe (dropper). This should be used to help you measure
the exact amount of medicine you need.
Follow these procedures:

• 1. Remove the child-resistant cap. Press down on the screw cap and rotate it counterclockwise simultaneously (Figure 1).
• 2. Insert the syringe into the bottle.
• 3. Holding the lower ring firmly, pull up the upper ring to the mark corresponding to the amount in milliliters or mg to be taken (Figure 2).
• 4. Holding the lower ring, remove the entire syringe from the bottle (Figure 3).
• 5. Empty the contents of the syringe into any non-alcoholic beverage, except tea. Slide the upper ring down.
• 6. Close the bottle.
• 7. Rinse the syringe with a little water.

If you use more Risperidone Mylan Generics than you should

• Consult your doctor immediately. Bring the medicine packaging with you.
• In case of overdose, you may feel sleepy or tired, or have strange body movements, problems standing and walking, dizziness caused by low blood pressure, or abnormal heartbeat or convulsions.

If you forget to take Risperidone Mylan Generics

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses together) to make up for a forgottendose.

If you stop taking Risperidone Mylan Generics
Do not stop taking this medicine unless your doctor tells you to do so. Your
symptoms may return or nausea, vomiting, sweating, difficulty
sleeping and involuntary movements may occur. If your doctor decides to stop this medicine, your
dose may be gradually reduced over several days.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately or go to the emergency room of a hospital if you experience any of the
following side effects:

Common (may affect up to 1 in 10 people):

• Develops lung infections, including serious infections such as pneumonia - may have a very high temperature, cough and sputum that may contain blood or be frothy and may feel very unwell

Uncommon (may affect up to 1 in 100 people):

• Sudden weakness or numbness of the face, arms or legs, especially on one side, or problems with vision or difficulty speaking that lasts for less than 24 hours. These may be signs of a mini-stroke (transient ischemic attack), a stroke, or reduced blood flow to the brain.
• An abnormal heart rhythm, such as a palpitation (fibrillation) or a very slow or abnormal heartbeat (heart block). These may be caused by abnormal electrical conduction of the heart and may be observed with an abnormal tracing of the heart's activity (ECG). In some cases, this may be life-threatening.
• If you do not respond to stimuli (changes in the internal or external environment), are slightly conscious or fall unconscious, or experience convulsions.
• Rhythmic involuntary movements of the tongue, mouth or face. It may be necessary to discontinue risperidone.
• Onset of diabetes - a condition in which the body is unable to properly control blood sugar levels. You may feel thirsty and yet urinate a lot, have an increased appetite but feel tired and lethargic. If left untreated, this can cause coma or complications of uncontrolled diabetes may develop, potentially life-threatening.
• Infections with symptoms such as fever and severe deterioration of general condition or fever with symptoms of local infection such as sore throat/mouth. Risperidone may cause a severe reduction in the number of white blood cells and resistance to infections may decrease. The

a blood sample will be taken to check for a possible reduction in white blood cells. It is important to tell your doctor that you are taking this medicine.

• Inhaling food into the airways, causing an infection or has congestion of the lungs (e.g. due to the formation of mucus).
• Having a skin infection, usually in the fatty layers of the thighs and buttocks (cellulitis)
• Has an inability to urinate or incomplete emptying of the bladder,
• Has severe constipation, which may be due to an obstruction of the intestine or severe hardening and compaction of the stool.

Rare (may affect up to 1 in 1,000 people):

• A severe allergic reaction with difficulty breathing and shock, swelling of the face, sudden swelling of the lips and eyes, tongue or throat, difficulty swallowing, hives, drop in blood pressure
• Unexplained muscle pain, muscle cramps or muscle weakness (rhabdomyolysis)
• Formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• Fever, muscle rigidity, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary.
• Prolonged and painful erection. This is called priapism. Immediate medical treatment may be necessary.
• Severe stomach pain that also reaches the back. This may be a symptom of inflammation of the pancreas
• Increased eye pressure (glaucoma), which can cause vision problems and long-term serious vision problems.
• A lower than normal level of sodium in the blood, which can make you weak and confused with muscle pain. This may be due to inappropriate secretion of a hormone (ADH) that causes fluid retention in the body and dilutes the blood, reducing the amount of sodium. This may be associated with dangerously excessive water intake (more than 2 liters per day).

Very rare (may affect up to 1 in 10,000)

• Loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slowed heartbeat, unusual muscle pain or feeling weak, tired or unwell. These may be signs of a rare, life-threatening complication of uncontrolled diabetes, called diabetic ketoacidosis.

The following side effects may also occur:

Very common (may affect more than 1 in 10 people):

• Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may occur with a frequency of less than 1 in 10 people. Parkinsonism includes: increased saliva secretion or watery mouth, musculoskeletal rigidity, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling steps, hurried and lack of normal arm movements during the

walk, persistent blinking in response to taps on the forehead (as an abnormal reflex)

• Headache, difficulty falling asleep or staying asleep.
• Drowsiness, sleepiness.

Common (may affect up to 1 in 10 people):

• Fatigue, restlessness, inability to sit still, anxiety, drowsiness, depression, dizziness, feeling excessively tired, sleep disturbances.
• Vomiting, diarrhea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache.
• Weight gain, increased body temperature, increased appetite, decreased appetite.
• Shortness of breath, influenza, blurred vision, eye infection or allergic reactions that can produce a viscous secretion, sinus infection, nasal congestion, nosebleeds, cough.
• Urinary tract infection, nocturnal emission, inability to control urine (incontinence).
• Tremor, muscle spasm, involuntary movements of face, arms and legs, repetitive movements or abnormal postures associated with muscle contractions, muscle and joint pain, back pain, fluid retention in the body (e.g. swelling of arms and legs, pain in arms and legs.
• Skin rash, skin redness, ear infection.
• Increased heart rate, chest pain, high blood pressure.
• Falls
• Increased level of the hormone prolactin in the blood.

Uncommon (may affect up to 1 in 100 people):

• Excessive water consumption, thirst, fecal incontinence, thirst, flatulence, hoarseness or voice disturbance.
• High blood sugar levels
• Bladder infection, viral infection and other infections, tonsil infection, stomach infection, nail yeast infection.
• Drop in blood pressure when standing up, low blood pressure, dizziness after changing position, perception of heartbeat, decreased heartbeat.
• Pain when passing urine, frequent need to urinate.
• Confusion, difficulty concentrating, excessive sleepiness, nightmares, nervousness, euphoric mood (mania).
• Increased liver enzymes, decreased hemoglobin or red blood cells (anemia), increased eosinophils (particular white blood cells), increased blood creatine phosphokinase, decreased platelets (blood cells that help stop bleeding), increased cholesterol in the blood.
• Muscle weakness, excessive restlessness associated with muscle spasms and tremor, ear pain, neck pain, swollen joints, abnormal posture, stiff joints, discomfort in the chest.
• Skin injury, skin disorders, dry skin, intense itching of the skin, acne, hair loss, eczema (skin inflammation) that may be caused by mites, skin discoloration

thickening of the skin, redness, sensation of tingling, reduced sensitivity
of the skin to pain or touch, inflammation of oily skin.

• Absence of menstrual cycle, sexual dysfunction, erectile dysfunction, ejaculation disorder, vaginal secretions, enlargement of the breasts in men, pain or discomfort in the breasts, reduced sexual drive, irregular or delayed menstrual cycle, vaginal discharge.
• Fainting, gait disturbance (way of walking), weakness, weight loss, decreased appetite leading to malnutrition and weight loss, feeling of “bad mood”, balance disorders, allergy, chills, abnormal coordination, altered taste.
• Painful sensitivity to light, increased blood flow to the eye, dry eye, increased tearing.
• Rough breathing sound, difficulty speaking, difficulty swallowing, coarse/wheezing sound during breathing.
• Ringing in the ears, feeling of dizziness and vertigo, facial swelling.

Rare (may affect up to 1 in 1,000 people):

• Inability to achieve orgasm, enlargement of the breasts or breasts swollen, warm and sensitive.
• Dandruff.
• Cold arms and legs, swelling of the tongue, inflammation of the lips, hardening of parts of the body, e.g. skin.
• Inability to move or respond when awake (catatonia)
• Sleepwalking
• Eating disorder related to sleep
• Formation of crusts on the edge of the eyelids, rolling of the eyes, problems with eye movements, complications during cataract surgery.
• Lack of emotions.
• Drug withdrawal syndrome
• Decreased body temperature
• Fast and shallow breathing, breathing problems during sleep, sinus arrhythmia (a normal variation in heart rate caused by breathing).
• Movement disorders.
• Head tremor.
• Yellowing of skin and eyes (jaundice).
• Presence of sugar (glucose) in the urine, low blood sugar, increased levels of insulin or fats (triglycerides) in the blood.

Very rare (may affect up to 1 in 10,000):

• Intestinal blockage (persistent constipation, with abdominal bloating and vomiting)

The following side effects have been observed with the use of another medicine called
paliperidone which is very similar to risperidone, so these effects may also be expected with
Risperidone Mylan Generics: fast heartbeat when getting up.

Additional effects in children and adolescents
In general, side effects in children are expected to be similar to those in adults. The
following side effects have been reported more frequently in children and adolescents (aged 5 to 17
years) than in adults: drowsiness or reduced alertness, fatigue, headache,
increased appetite, vomiting, cold symptoms, nasal congestion, abdominal pain,
dizziness, cough, fever, tremor, diarrhea and urinary incontinence.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Risperidone Mylan Generics

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or bottle. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Do not refrigerate or freeze. Store in the
original packaging.
After opening the bottle, any unused portion of Risperidone Mylan Generics oral solution,
must be discarded after 4 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Risperidone Mylan Generics contains

• The active ingredient is risperidone. 1 ml of oral solution contains 1 mg of risperidone.
• The other ingredients are: tartaric acid (E334), benzoic acid (E210), hydrochloric acid and purified water.

Description of the appearance of Risperidone Mylan Generics and contents of the pack
Risperidone Mylan Generics oral solution: is clear and colourless. The medicine is available in
amber glass bottles with a child-resistant cap containing 30 ml, 60 ml, 100 ml and 120
ml.
To facilitate accurate measurement, a syringe (dropper) is provided. A pipette cleaner and a protective sheath are also provided.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 – 20124 Milan, Italy

Manufacturer Responsible for batch release
Generics (UK) Ltd
Station Close, Potters Bar, Hertfordshire
EN6 1TL, United Kingdom
McDermott Laboratories Ltd (t/a Gerard Laboratories)
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13, Ireland
Chanelle Medical
Loughrea Industrial Estate, Co. Galway
Ireland
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Risperidon Mylan 1mg/ml drank
Germany: Risperidon dura 1 mg/ml Lösung zum Einnehmen
Italy: Risperidone Mylan Generics
Netherlands: Risperidon drank Mylan 1mg/ml, drank
Portugal: Risperidona Mylan1mg/ml, soluçaö oral
Slovenia: Risperidon Mylan
Spain Risperidona Mylan 1mg/ml solución oral EFG
United Kingdom: Risperidone 1 mg/ml oral solution